BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    DEKA ARM SYSTEM

    K Number: DEN120016 · Decision May 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    693

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    Basic Information

    Device Name
    DEKA ARM SYSTEM
    K Number
    DEN120016
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    890.3450
    Medical Specialty
    Physical Medicine
    Decision
    Unknown
    Applicant
    Deka Integrated Solutions Corporation
    Date Received
    June 15, 2012
    Decision Date
    May 9, 2014
    Product Code
    PAE
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PAE Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography